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PROMINENT-Eye Ancillary Study (Protocol AD)

Primary Purpose

Diabetic Retinopathy, Diabetic Macular Edema

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pemafibrate
Placebo
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring pemafibrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Already randomized at US or Canadian sites in the PROMINENT study
  • Ability to cooperate with dilated ophthalmic examination and imaging procedures

  • At least one eye meets the following study eye inclusion criteria:

    1. Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading.

Exclusion Criteria:

  • Study eye exclusion criteria are:

    a. Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the prior year for any indication.

    f. History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging

Sites / Locations

  • Arizona Retina and Vitreous Consultants
  • Retinal Diagnostic Center
  • Macula & Retina Institute
  • Atlantis Eye Care
  • Loma Linda University Health Care, Department of Ophthalmology
  • South Coast Retina Center
  • Northern California Retina Vitreous Associates
  • Retinal Consultants of Southern California Medical Group, Inc.
  • National Ophthalmic Research Institute
  • University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent
  • Florida Retina Consultants
  • Retina Macula Specialists of Miami
  • Florida Retina Institute
  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
  • Sarasota Retina Institute
  • Emory Eye Center
  • Emory Eye Center
  • Southeast Retina Center, P.C.
  • Thomas Eye Group
  • Northwestern Medical Faculty Foundation
  • Northwestern Medical Faculty Foundation
  • University of Illinois at Chicago Medical Center
  • NorthShore University HealthSystem
  • Illinois Retina Associates, S.C.
  • John-Kenyon American Eye Institute
  • Wolfe Eye Clinic
  • Mid-America Retina Consultants, P.A.
  • Retina Associates, P.A.
  • Retina and Vitreous Associates of Kentucky
  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  • Elman Retina Group, P.A.
  • Wilmer Eye Institute at Johns Hopkins
  • Valley Eye Physicians and Surgeons
  • Ophthalmic Consultants of Boston
  • Joslin Diabetes Center
  • Kellogg Eye Center, University of Michigan
  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
  • Vitreo-Retinal Associates
  • Retina Center, PA
  • Retina Center, PA
  • The Retina Institute
  • Eye Associates of New Mexico
  • Eye Associates of New Mexico
  • MaculaCare
  • Retina Associates of Western New York
  • Retina-Vitreous Surgeons of Central New York, PC
  • Western Carolina Clinical Research, LLC
  • Kittner Eye Center
  • Kittner Eye Center
  • Charlotte Eye, Ear, Nose and Throat Assoc., PA
  • Retina Vitreous Center
  • Dean A. McGee Eye Institute
  • Retina Vitreous Consultants
  • Southeastern Retina Associates
  • Southeastern Retina Associates, P.C.
  • Retina Research Center
  • Robert E. Torti, MD, PA dba Retina Specialists
  • Valley Retina Institute
  • Retina Center of Texas
  • Baylor Eye Physicians and Surgeons
  • Baylor Eye Physicians and Surgeons
  • Retina Consultants of Houston, PA
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retinal Consultants of San Antonio
  • Retina Institute of Virginia
  • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
  • UBC/VCHA Eye Care Centre
  • University Health Network - Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pemafibrate

Placebo

Arm Description

.2 mg pemafibrate orally BID

Placebo pill orally BID

Outcomes

Primary Outcome Measures

Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome)

Secondary Outcome Measures

Full Information

First Posted
November 7, 2017
Last Updated
August 27, 2020
Sponsor
Jaeb Center for Health Research
Collaborators
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03345901
Brief Title
PROMINENT-Eye Ancillary Study (Protocol AD)
Official Title
PROMINENT-Eye Ancillary Study: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate Versus Placebo (Protocol AD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
recruitment for the substudy did not meet the goals
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
Kowa Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed countries worldwide. Thus, even a modest ability to prevent DR onset or to slow DR worsening might substantially reduce the number of patients at risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at reducing worsening of DR might also decrease the numbers of patients who undergo treatment for DR and diabetic macular edema (DME) and who are consequently at risk for side effects that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in progression of retinopathy in patients with diabetes assigned to fibrate compared with placebo. However, despite the positive clinical trial results, fenofibrate has not gained wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care providers. Thus, it is important to provide further evidence demonstrating whether or not selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study for prevention of cardiovascular events in patients with type 2 diabetes. Given the large study cohort with a substantial proportion likely to have DR and the multi-year duration of the PROMINENT trial, this study represents a unique opportunity to assess effects of chronic PPARα activation through pemafibrate therapy on DR outcomes. Primary Study Objective: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetic Macular Edema
Keywords
pemafibrate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemafibrate
Arm Type
Experimental
Arm Description
.2 mg pemafibrate orally BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill orally BID
Intervention Type
Drug
Intervention Name(s)
Pemafibrate
Intervention Description
0.2 mg orally BID - twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally BID - twice daily
Primary Outcome Measure Information:
Title
Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Already randomized at US or Canadian sites in the PROMINENT study Ability to cooperate with dilated ophthalmic examination and imaging procedures At least one eye meets the following study eye inclusion criteria: Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading. Exclusion Criteria: Study eye exclusion criteria are: a. Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the prior year for any indication. f. History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Chew, MD
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Retina and Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Macula & Retina Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Atlantis Eye Care
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Loma Linda University Health Care, Department of Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
South Coast Retina Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retinal Consultants of Southern California Medical Group, Inc.
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Retina Macula Specialists of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeast Retina Center, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Thomas Eye Group
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2987
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Illinois Retina Associates, S.C.
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Mid-America Retina Consultants, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Retina Associates, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Retina and Vitreous Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291-4452
Country
United States
Facility Name
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Wilmer Eye Institute at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Valley Eye Physicians and Surgeons
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Kellogg Eye Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Facility Name
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Retina Center, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
34239
Country
United States
Facility Name
Retina Center, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109-5857
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
MaculaCare
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Retina-Vitreous Surgeons of Central New York, PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Western Carolina Clinical Research, LLC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517-8923
Country
United States
Facility Name
Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Assoc., PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Vitreous Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Retina Vitreous Consultants
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Southeastern Retina Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Southeastern Retina Associates, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Robert E. Torti, MD, PA dba Retina Specialists
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115-2011
Country
United States
Facility Name
Valley Retina Institute
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Retina Center of Texas
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Baylor Eye Physicians and Surgeons
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4101
Country
United States
Facility Name
Baylor Eye Physicians and Surgeons
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
UBC/VCHA Eye Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data related to the eye ancillary study will be made available after completion of the study and publication of the outcome manuscript.

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PROMINENT-Eye Ancillary Study (Protocol AD)

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